FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. Had only animal studies been used, telcagepant and MK3207 may well have gone on to harm humans.

Animal Testing 147

Animal Testing Disease Trials Research 147

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research 52

Clinical Research Research Clinical Trials Laboratories 52

Drug Discovery World

JANUARY 21, 2024

Bushell will discuss the history and technological underpinnings of induced proximity, the lessons learned from the PROTAC (proteolysis-targeting chimeric) example, and how technology can create enhancement-targeting chimeric, or ENTAC, drugs and fully realise the potential of targeted protein enhancement. Is pharma’s commercial model dying?

Vaccine 130

Vaccine Computational Chemistry Animal Testing Engineering 130

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs 111

Drugs FDA Disease Animal Testing 111

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA 40

FDA Science Small Molecule Immune Response 40